Soluscope
Contents
1. 3131375813 aupr s du pr fet de la r gion Provence Alpes C te d Azur2. D05175 Soluscope EC MANUFACTURER S DECLARATION OF CONFORMITY D claration de conformit CE du Fabricant FULL QUALITY ASSURANCE SYSTEM Syst me complet d Assurance de Qualit Manufacturer s Name Nom du Fabricant SOLUSCOPE Address Adresse 100 rue du Fauge ZI Les Paluds 13400 AUBAGNE FRANCE Product Reference R f rence du produit SOLUSCOPE SERIE 1 SL V1 PA and SL V1 GTA Classification of the Medical Device Classe du Dispositif M dical Class Il b Classe Il b Annex IX Rule number 15 Annexe IX R gle n 15 Type designation D signation Washer disinfector Laveur d sinfecteur Scope of Application Domaine d application Flexible endoscope reprocessing to be used exclusively with SOLUSCOPE NW or SOLUSCOPE EZ detergents and SOLUSCOPE PA or SOLUSCOPE GTA disinfectants according to the user manual Nettoyage et d sinfection des endoscopes souples utiliser exclusivement avec les d tergents SOLUSCOPE NW ou SOLUSCOPE EZ et les d sinfectants SOLUSCOPE PA ou SOLUSCOPE GTA conform ment au manuel d utilisation GMDN Code amp Term 35628 Washer decontamination endoscope Code amp D signation GMDN flexible Notified Body 0843 UL International UK Ltd Organisme notifi Quality management System according to ISO 9001 2008 Certificate No and to ISO 13485 2003 10383939 Certificate Expiry 06 Sept 2017 CE Marking Certificate No Marq
3. uage CE 537 Certificate Expiry 06 Sept 2017 I undersigned Jean Fran ois BIRY C E O of SOLUSCOPE SAS declare that the above mentioned device complies with the relevant provisions according to the European Directive 93 42JEEC concerning Medical Devices as amended Annex II with exemption of section 4 as transposed in the French decree N 2009 482 of 28 April 2009 and particularly fulfils the Essential Requirements according to the Annex l consequently the CE mark is affixed on the above cited device Je soussign Jean Fran ois BIRY P D G de SOLUSCOPE SAS d clare que le dispositif m dical d crit ci dessus est conforme aux dispositions qui le concernent selon l Annexe Il l exception du point 4 de la Directive Europ enne 93 42 CEE amend e relative aux Dispositifs M dicaux transpos e en droit fran ais dans le d cret N 2009 482 du 28 04 2009 et en particulier satisfait aux Exigences Essentielles de l Annexe l en cons quence la marque CE est appos e sur ce dispositif m dical Jean Frag ois BIRY Soluscghe C E O Date November 11 2014 www soluscope com 100 rue du Fauge Z I Les Paluds 13400 Aubagne France T l 33 0 4 91 83 21 22 Fax 33 0 4 91 83 21 10 E mail info soluscope com Soluscope SAS au capital de 11 700 000 Code APE 3250 A RCS Marseille 490918075 N TVA intracommunautaire FR 36490918075 Siret 49091807 500048 Organisme de formation enregistr sous le num ro 9
Download Pdf Manuals
Related Search
Soluscope soluscope soluscopepro soluscope login soluscope sprint soluscope aubagne soluscope pa soluscope serie 4 soluscope anios soluscope cln soluscope sas soluscope sprint pt soluscope p sds soluscope 4 soluscope ent soluscope sprint user manual